BEACITA*84CPS 60MG

BEACITA 60 mg hard capsules
Orlistat

What it is and what it is used for
BEACITA is a peripherally acting anti-obesity drug used for weight loss in adults aged 18 and over who are overweight, with a body mass index (BMI) of 28 or higher. BEACITA should be used in conjunction with a reduced-calorie, reduced-fat diet.

BMI is a way to assess whether your weight is healthy or if you are overweight for your height. The table below will help you determine if you are overweight and if BEACITA is suitable for you.

Risks associated with being overweight
Being overweight increases the risk of developing several serious health problems, such as diabetes and cardiovascular disease. These conditions may not cause noticeable symptoms, so you should consult your doctor for a general health check-up.

How BEACITA works
The active ingredient in BEACITA (orlistat) is designed to act on fats in the digestive system.
This substance blocks the absorption of approximately one quarter of the fats present in meals. These fats are then eliminated from the body in the faeces (see section 4). It is therefore important to commit to a low-fat diet to help control these effects. In doing so, the effect of the capsules will support your efforts, helping you to lose more weight than with diet alone. For every 2 kg lost with diet alone, BEACITA could help you lose up to 1 kg more.

What you need to know before taking the medicine
Do not take BEACITA
- If you are allergic to orlistat or any of the other ingredients of this medicine (listed in section 6).
- If you are pregnant or breastfeeding.
- If you are taking ciclosporin, a medicine used after organ transplants, for severe forms of rheumatoid arthritis and some severe skin diseases.
- If you are taking warfarin or other medicines used to thin the blood.
- If you suffer from cholestasis (a condition in which the flow of bile from the liver is blocked).
- If you suffer from problems with food absorption (chronic malabsorption syndrome)
- diagnosed by a doctor.

Warnings and precautions
Talk to your doctor or pharmacist before taking BEACITA.
- If you have diabetes, tell your doctor who may need to adjust the dose of your antidiabetic medicine.
- If you have kidney disease. Consult your doctor before taking BEACITA if you have kidney problems.
The use of orlistat may be associated with kidney stone formation in patients suffering from chronic kidney disease.

Children and adolescents
This medicine should not be taken by children and adolescents under 18 years of age.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.

Most of BEACITA's side effects (e.g., intestinal gas with or without oily spotting, sudden or more frequent bowel movements, and soft stools) are caused by its mechanism of action (see section 1). Eat low-fat meals to help control these diet-related treatment effects.

Serious side effects The frequency of these side effects is not known.

Severe allergic reactions
- Signs of a severe allergic reaction include: severe difficulty breathing, sweating, rash, itching, facial swelling, rapid heartbeat, collapse.
Stop taking the capsules. Seek immediate medical attention.

Other serious side effects
- Rectal bleeding
- Diverticulitis (intestinal inflammation). Symptoms may include abdominal pain, especially on the left side, possibly accompanied by fever and constipation.
- Pancreatitis (inflammation of the pancreas). Symptoms may include severe abdominal pain sometimes radiating to the back, possibly accompanied by fever, nausea and vomiting.
- Skin blisters (including blistering that ruptures)
- Severe abdominal pain caused by gallstones
- Hepatitis (inflammation of the liver). Symptoms may include yellowing of the skin and eyes, itching, dark urine, abdominal pain and tenderness of the liver (indicated by pain under the front right side of the rib cage), sometimes with loss of appetite.
- Oxalate nephropathy (calcium oxalate deposits that can form kidney stones).
See section 2 Warnings and precautions.
Stop taking the capsules. If you experience any of these effects, contact your doctor.

Very common side effects
May affect more than 1 in 10 people
- Intestinal gas (flatulence), with or without oily spotting
- Sudden bowel movements
- Fatty or oily stools
- Soft stools.
Tell your doctor or pharmacist if any of these effects become severe or concerning.

Common side effects
May affect up to 1 in 10 people
- Abdominal pain (stomach)
- Incontinence (faecal)
- Watery/liquid stools
- More frequent bowel movements
- Anxiety
- Urinary tract infection.
Tell your doctor or pharmacist if any of these effects become severe or concerning.

Effects on blood tests
The frequency of occurrence is not known (frequency cannot be estimated from the available data)
- Increase in levels of some liver enzymes
- Effects on blood clotting in patients taking warfarin or other anticoagulants.
Tell your doctor that you are taking BEACITA while undergoing blood tests.

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.